Intervertebral spacer that dynamically promotes bone growth

ABSTRACT

A dynamic intervertebral spacer includes a ring which is split on an anterior portion. A posterior portion of the ring acts as a torsion spring. After implantation, the ring is able to act as a spring between superior and inferior vertebral bodies, thus allowing dynamic bone growth in fusion procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/065,774, filed on Mar. 9, 2016, which claims the benefit ofprovisional application No. 62/131,154, filed on Mar. 10, 2015, the fulldisclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medical devices and methods. Morespecifically, the invention relates to intervertebral spacers methodsfor dynamically promoting bone growth and fusion following implantationof the spacer.

Back pain takes an enormous toll on the health and productivity ofpeople around the world. According to the American Academy of OrthopedicSurgeons, approximately 80 percent of Americans will experience backpain at some time in their life. In the year 2000, approximately 26million visits were made to physicians' offices due to back problems inthe United States. On any one day, it is estimated that 5% of theworking population in America is disabled by back pain.

Common causes of back pain are injury, degeneration and/or dysfunctionof one or more intervertebral discs. Intervertebral discs are the softtissue structures located between each of the thirty-three vertebralbones that make up the vertebral (spinal) column. Essentially, the discsallow the vertebrae to move relative to one another. The vertebralcolumn and discs are vital anatomical structures, in that they form acentral axis that supports the head and torso, allow for movement of theback, and protect the spinal cord, which passes through the vertebrae inproximity to the discs.

When a damaged intervertebral disc causes a patient pain and discomfort,surgery is often required. Typically, surgical procedures for treatingintervertebral discs involve discectomy (partial or total removal of adisc), often followed by interbody fusion of the superior and inferiorvertebrae adjacent to the disc. Fusion is most commonly achieved byimplantation of a cage or spacer together with bone graft material topromote bone growth to fuse the adjacent vertebrae together. Oftentimes,pins, rods, screws, cages and/or the like are placed between thevertebrae to act as support structures to hold the vertebrae and bonegraft material in place while the bones permanently fuse together.

While such fusion procedures have been very successful for manypatients, it some cases the fusion spacers or cages can be difficult toimplant, and the bone regrowth necessary to achieve complete fusion cantake an excessive period of time. Therefore, a need exists for improvedspacers and methods for fusing the spacers to promote complete and rapidbone regrowth. At least some of these objectives will be met by theinventions described herein below.

2. Description of the Background Art

A compliant block intended to be implanted between adjacent vertebrae topromote fusion as described in U.S. Pat. No. 6,395,033. Partiallycompliant fusion cages and spacers are described in U.S. Pat. No.8,685,101 and U.S. Pat. Publ. 2009-0093885. An interspinous fusiondevice which dynamically promotes bone growth is described in U.S. Pat.Publ. 2013-0296940. Flexible devices which may be coiled and implantedbetween vertebrae are described in U.S. Pat. Nos. 7,666,226 and7,947,078. A bone implant that may have a U-shape is described in U.S.Pat. No. 6,652,592.

BRIEF SUMMARY OF THE INVENTION

The present invention provides alternative and improved apparatus andmethods for performing interbody spinal fusion procedures. Inparticular, improved fusion spacers are provided which are relativelycompact and simple to implant. The fusion cages are configured not onlyto fill the space between adjacent superior and inferior vertebrae afterdisc removal, they also provide for a compliant support which allowsrelative movement between the superior and inferior vertebrae as thepatient moves about and the patient's spine undergoes flexion andextension. The spacers have very simple designs, are easy tomanufacture, and provide for rapid attachment to the superior andinferior vertebral bodies while continuing to allow the desired relativemotion of the vertebral bodies to dynamically promote bone growth.

In a first aspect, the present invention provides a dynamicintervertebral spacer. The spacer comprises a ring having an anteriorportion, a posterior portion, a right lateral portion, a left lateralportion, and an open center portion. The ring is split in the anteriorportion, and superior and inferior surfaces on a right side thereof arevertically offset from superior and inferior surfaces on a left sidethereof. The posterior portion of the ring is configured to act as atorsion spring to allow the vertical offset between the right side andleft side of the ring to decrease under load on the superior andinferior surfaces of the ring. When the adjacent vertebral bodiesbetween which the spacers implanted are under minimal load, the offsetwill be maximum, and conversely when the adjacent vertebral bodies applya maximum load (compressive force) to the spacer, the vertical offsetwill be minimum. Thus, as the load increases and decreases, the spacingbetween the vertebral bodies will decrease and increase, respectively.Such dynamic loading has been found to promote tissue growth,particularly when bone graft materials were placed within the opencenter portion of the ring.

In exemplary embodiments, one of the superior and inferior surfaces onthe right side of the ring (but not the other) will have attachmentfeatures or adhesives which provide for attachment to an adjacentvertebral body and one of the superior and inferior surfaces on the leftside (but not the other) will have attachment features or adhesiveswhich provide for attachment to an adjacent vertebral body. By arrangingthe attachment features on opposite surfaces, i.e. one will be on asuperior surface and one will be on an inferior surface, a verticallyraised superior surface one side of the ring will be attached to thesuperior vertebral body while a vertically lowered inferior surface onthe other side of the ring will be attached to the inferior vertebralbody. Usually, the surfaces on the superior and inferior faces of thering which contact the bone will have features, coatings, or the likewhich promote bone ingrowth. In contrast, the surfaces on the ring whichare intended to remain out of contact with the adjacent vertebral bodieswill be free from such bone growth promoting and coatings. Alternativelyor additionally, the right and left sides of the ring may each have atleast one bone screw, with a bone screw on one side is configured toattach to a posterior vertebral body and the bone screw on the otherside of the ring is configured to attach to an inferior vertebral body.Some instances, more than one bone screw may be used on each side of thering.

The manner in which the ring is split on the interior surface may take avariety of forms or geometries. In an exemplary geometry, terminal faceson the right and left sides of a gap in the anterior portion of the ringwill each be flat, and optionally vertical. In other instances, theopposed faces may be non-planar. Such non-planar surfaces may defineseparation paths which are non-linear in either a superior-to-inferiordirection or in an anterior-to-posterior direction. Such non-linearseparation paths may be advantageous in that they help retain the bonegraft material within the open center portion of the ring.

In other specific embodiments, the ring consists of a monolithic body.Such monolithic bodies may be formed by casting, molding, machining, orthe like, and will be free from joints and other non-continuous regions.The monolithic bodies may be formed from a polymer, such as a poly etherketones (PEEK), polyaryl ether ketones (PAEK), and their composites,such as carbon fiber reinforced or with radiopaque compounds. In stillother instances, the monolithic body may consist of a metal. Exemplarymetals, include tantalum or titanium, and their alloys and compositessuch as nitinol, cobalt chrome molybdenum and variants. In addition, themetals may be either porous for the purpose of adjusting the bulkstiffness of the material, or for enhancing osteo-integration. Thedifferent metal morphologies may be a result of additive manufacturing,such as direct metal laser-sintering or vacuum sintering.

The vertical offset will typically be in the range of 0.05 mm to 3.0 mm,often from 0.1 mm to 1.75 mm, and usually from 0.2 mm to 1.0 mm. Theoffsets in the lumbar spine will typically be at the higher ends of thisrange while those in the thoracic spine will be toward the middle orlower middle and those in the cervical spine will be in the lowerportion of the offset. The material and structure of the ring willusually be selected so that the vertical offset resists compression witha spring force in the range from 20 N/mm to 40000 N/mm, usually from 150N/mm to 5000 N/mm, and typically from 250 N/mm to 1000 N/mm. In stillfurther specific embodiments, the superior surface of the spacer mayhave a convex or “domed” geometry.

In a second aspect in the present invention, a method for dynamicallyfusing adjacent vertebral bodies in a patient's spine comprisesimplanting a spacer between the adjacent vertical bodies (typicallyafter a discectomy or other procedure to remove the native disc). Anopen center of the spacer is filled with a bone graft material, and thesuperior and inferior surfaces on a right side of an anterior portion ofthe spacer are vertically offset from the superior and inferior surfaceon the left side of the anterior portion of the spacer. The spacer isconfigured so that the vertical offset elastically resists flexion asthe patient's spine goes through flexion and extension, or theresistance to flexion dynamically promotes bone growth.

The vertical offset typically has a magnitude in the ranges set forthabove and resists flexion with an elastic constant in the ranges setforth above. The vertical offset is typically formed by a space or gapbetween the superior surface and the adjacent vertebral body on one sideof the spacer and a gap or space between the inferior surface and theother adjacent vertebral body on the other side of the spacer. Thesegaps in turn allow the free surfaces of the spacer (which are notattached to a vertebral body) to move toward and away from the adjacentvertebral bodies to allow the desired dynamic motion between thosevertebral bodies. Typically, the surfaces on the spacer which arenormally in contact with the adjacent vertebral body surfaces will beattached to those vertebral body surfaces, in some way. For example,bone screws may be used to attach the surfaces. Alternatively, bonegrowth promoting features or coatings may be placed on those portions ofthe superior and inferior surfaces of the spacer which are intended tobe in contact with the adjacent vertebral bodies. Those surface portionswhich are intended to not be in contact with the vertebral bodies willof course be free of such bone attachment features.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A and 1B illustrate a first embodiment of a dynamicintervertebral spacer constructed in accordance with the principles ofthe present invention. FIG. 1A shows the dynamic intervertebral spaceroriented with the anterior portion downward to expose the superiorsurface of the spacer. FIG. 1B is a front or anterior elevation viewshowing the vertical offset of the right and left sides of the spacer.

FIGS. 2A through 2C are alternative views of the dynamic intervertebralspacer of FIGS. 1A and 1B shown with the bone anchoring screws removed.

FIGS. 3A and 3B illustrate a first alternative design of a dynamicintervertebral spacer of the present invention.

FIGS. 4A and 4B illustrate a second alternative design for anintervertebral spacer of the present invention.

FIGS. 5A-5C illustrate a second alternative design for an intervertebralspacer of the present invention. FIG. 5A is a view of the anterior sideof the spacer while FIGS. 5B and 5C are views of the inferior andsuperior surfaces, respectively.

FIG. 6 is a side or lateral view of the dynamic intervertebral spacer ofFIGS. 1A and 1B shown implanted between a superior vertebral body and aninferior vertebral body.

FIG. 7 is a view of the implanted dynamic intervertebral spacer FIG. 6shown from a front or anterior perspective.

FIG. 8 illustrates the implantation of a dynamic intervertebral spacerin combination with a dynamic bone plate.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1A and 1B, a dynamic intervertebral spacer 10comprises a ring 12 (which forms a body thereof) having an anteriorportion 14, a posterior portion 16, a right lateral portion 18, a leftlateral portion 20, and an open center 22. The ring as illustrated hasfour sides with the posterior portion 16 being slightly wider than theanterior portion 14. The ring will also have a depth in a horizontal oranterior-posterior direction and a thickness in the vertical orsuperior-inferior direction. Representative dimensions for the exemplaryring for each of three intended implantation locations (lumbar,thoracic, and cervical) are set forth in Table I below.

TABLE I Anterior Posterior Vertical Width Width Depth Thickness OffsetLUM- 30-50 mm 25-45 mm 25-40 mm 8-15 mm   0.1-3 mm BAR THO- 23-36 mm15-29 mm 17-30 mm 4-9 mm 0.1-2.5 mm RACIC CER- 14-20 mm 14-20 mm  3-8 mm3-8 mm 0.1-1.75 mm  VICAL

The specific geometry and dimensions set forth above are not criticaland are meant to be exemplary only. Other geometries, such as circular,oval, triangular, rectangular, polygonal, and the like, may also finduse. In all cases, however, there will be at least one break in the ringto form a gap 24 between opposed free ends of the ring. The free ends ofthe ring will be vertically offset by a small distance, typically in theranges set forth above in the Summary, in order to allow the spacer toact as a “spring” when implanted between a lower surface of a superiorvertebral body and an upper surface of an inferior vertebral body, willbe described in more detail below. Representative vertical offsets areprovided in Table I for each of the different implantation regions.

The vertical offset and the dimensions of the spacer will correspond toa particular designed range of motion in the anterior/posteriordirection for the spacer. A range of motion of 0.1-2 degrees is selectedto achieve fusion quickly while a range of motion 3-6 degrees can beused to gradually transition to fusion over a period of about 2-3 years.A range of motion of 6 degrees or greater can be used to maintain motionwithout fusion.

Referring now to FIGS. 2A through 2C, the ring 12 of the dynamicintervertebral spacer 10 may optionally be modified to promote boneingrowth over certain selected regions thereof. As shown in FIGS. 2A and2C, a superior bone attachment region 36 may be formed over the rightlateral portion 18 and over a right side of the posterior portion 16 ofthe device. It will be appreciated that these attachment regions on thesuperior surface are elevated relative to the superior surface leftlateral portion 20 and will be in contact with the lower surface of thesuperior vertebral body when the spacer is implanted. The surfacemodifications may be features, such as ridges, grooves, and the like, ormay alternatively comprise coatings selected to promote bone ingrowth,such as titanium plasma spray or hydroxyapetite. The surfacemodifications will be in addition to, or in some cases in place of, useof a superior bone attachment screw 26 which is received in an inferiorscrew hole 52 in the anterior portion of the right lateral portion 18 ofthe ring.

Surface modifications to promote bone ingrowth may also be provided onthe walls of the open center 22 to promote bone attachment through thecenter of the ring 12 between the vertebrae. Coatings on the wall of theopen center 22, such as titanium coatings on a polymer or PEEK ring,will encourage bone to grow through the ring to form a dynamic fusion.

An inferior bone attachment region 38 will typically be formed over theinferior surface of the left lateral portion 20 of the ring 12, as shownin FIG. 2C. The inferior bone attachment region will typically have thesame characteristics as the superior bone attachment region 36, and maybe used together with or in place of an inferior bone attachment screw28 which is received through the superior screw hole 50 on an anteriorregion of the left lateral portion 20.

Referring specifically to FIG. 2B, the right lateral portion 18 and theleft lateral portion 20 of the ring 12 are vertically offset to createan offset 46, as best seen in FIG. 2B. Exemplary vertical offsets areset forth in Table I above. It is this differential or offset whichallows the ring 12 to act as a spring when implanted between superiorand inferior vertebral bodies. In the particular ring design 12, thebending or spring constant of the ring will be defined by the torsionalstiffness of the posterior portion 16. That is, the right lateralportion 18 and left lateral portion 20 will act as bending armsconnected to the posterior portion 16, were the posterior portion actsas a torsional spring. Particular spring constants have been set forthabove. The intervertebral spacer 10 provides compliant support betweenvertebrae during growth of bone through the spacer and provides agradual transition from motion to fusion.

Although the intervertebral spacer 10 has been designed with an anteriorgap 24 and a posterior portion 16 acting as a torsion spring, the spacermay be configured with one or more gap and one or more torsion springportions moved to anterior, posterior or lateral locations depending onthe desired motion of the spacer.

Referring now to FIGS. 3A and 3B, the gap between the right lateralportion and left lateral portion of the intervertebral spacer of thepresent invention may take a variety of forms and geometries. In analternative ring construction 60 of FIGS. 3A and 3B, a right lateralportion 66 and left lateral portion 68 of the ring have a gap 74 whichis linear in the anterior-posterior direction but non-linear in thesuperior-inferior direction. In particular, the gap 74 is has a stepdefined by an inferior tab 74 a and a superior tab 74 b which togetherform an opening which has two vertical portions joined by a horizontalportion. The right lateral portion 66 and left lateral portion 68 arevertically offset relative to each other, where the degree of verticaloffset is limited by the tabs which will in turn also limit the degreeof extension to prevent excessive extension. The ring 60 will also havean anterior portion 62, a posterior portion 64, and a superior boneattachment region 70 having any of the characteristics previouslydescribed as well as a superior region 72 which is free from any boneattachment features. Although not illustrated, the ring 60 willtypically also be configured to receive bone attachment screws, and theinferior surface of the ring will also have a bone attachment region onthe right lateral portion and region free from bone attachment featureson the left lateral portion.

Referring now to FIGS. 4A and 4B, a further alternative ring 80 issimilar to the previously described embodiments, but includes a gapregion 94 which is linear in the superior to inferior direction andnon-linear in the anterior to posterior direction. Particular, the ring80 has an anterior portion 82, a posterior portion 84, a right lateralportion 86, and a left lateral portion 88. A superior bone attachmentregion 90 is formed over the right lateral portion 86 which is raisedrelative to the left lateral portion 88. A superior surface 92 of theleft lateral portion 88 is free from bone detachment features. The gap94 is shown to include two axial lengths in the anterior-to-posteriordirection joined by a lateral length in the lateral direction. The useof non-linear gap regions is advantageous as in can help retain the bonegraft material in the open centers of the rings.

Referring now to FIGS. 5A-5C, dynamic and intervertebral spacesaccording to present invention may be formed from one or more ringstructures, typically joined in a monolithic or integrated geometry. Inparticular, ring 100 has an anterior portion 102, a posterior portion104, a right lateral portion 106, and a left lateral portion 108. Inaddition, a center region 110 is formed between the right lateralportion and left lateral portion, defining a right open region 112 and aleft open region 114. One of the gaps 122 opens into the right openregion 112 and the other of the gaps 122 opens into the left open region114. In this way, the center region 110 is “cantilevered” from theposterior region 104 and is free to move in the vertical directionrelative to both lateral portions 106 and 108. In the illustratedembodiment, the center region 112 is raised relative to the right andleft lateral portions 106 and 108 when unconstrained so that, onceimplanted, a superior surface 120 of the center region 112 will engagethe lower surface of an adjacent, superior vertebral body. Conversely,the inferior surfaces of the both the right lateral portion 106 and leftlateral portion 108 will contact the superior surface of the inferiorvertebral body. A vertical offset remains between the inferior surfaceof the center portion 110 and the superior surface of the inferiorvertebral body, thus allowing the desired dynamic vertical movement ofthe vertebral bodies to promote bone growth. The ring 103 will typicallyinclude bone attachment screws (not shown), including at least one foreach lateral region and one for the center region. Additional, boneattachment regions 116 and 118 will typically be formed on the inferiorsurfaces of the right lateral portion 106 and left lateral portion 108,as shown in FIG. 5B which is a bottom plan view of the ring 100. Incontrast, the inferior surface 120 of the center region 110 will be freefrom such features as bone attachment is not desired. The boneattachment regions on the superior surface of the ring 100 will bearranged opposite to the arrangement on the inferior surface, i.e. thesuperior surface 121 of the center portion 110 will have bone attachmentfeatures while the superior surfaces of the right lateral portion 106and left lateral portion 108, as shown in FIG. 5C which is a top planview of the ring 100, are free from such attachment features.

Referring now to FIGS. 6 and 7, implantation of the dynamic spacer 10 ofFIGS. 1A, 1B and 2A-2C is illustrated. The posterior portion 14 of thering 12 is directed toward the patient's posterior while the anteriorportion 14 is directed toward the patient's anterior. The gap 24 (bestseen in FIG. 7) is thus aligned with the anterior surfaces of thevertebral bodies, allowing movement as the patient's spine experiencesflexion and extension.

Referring now to FIG. 8, the dynamic intervertebral spacers of thepresent invention may be used in combination with other dynamicvertebral stabilization devices, such as a dynamic bone plate 130 whichmay be implanted after implantation of the dynamic intervertebral spacer10.

In use, the dynamic intervertebral spacer provides a transition betweena full range of motion and complete spinal fusion. For example, if apatient prior to surgery has a natural range of motion of the naturaldisc in the anterior/posterior direction of about 6 degrees, a dynamicspacer may be implanted having a range of motion of about 3 degrees andthe patient's range of motion immediately post-surgery is expected to beabout 3 degrees. As the bone of the patient grows into and through thespacer, the range of motion may be decreased further to about 1-2degrees or less upon complete growth of bone bridging between the twovertebrae. The reduction in range of motion gradually over time canimprove patient outcomes and allow the patient's natural anatomy tobetter accommodate the fusion. Allowing some motion between thevertebrae promotes bone growth and can accelerate the timeframe untilcomplete fusion is achieved. The amount of motion allowed by the dynamicspacer can be selected depending on the anatomy and/or range of motionof the particular patient. A method of selecting a dynamic spacer mayinclude steps of measuring the natural range of motion of the patient atthe level of the desired surgery and selecting a dynamic spacer with arange of motion limited to an amount less than the natural range ofmotion. The selected spacer may have a range of motion of about 2 ormore degrees less than the natural range of motion.

A timeframe for transition to complete fusion can vary and depends onthe amount of motion. For motion of about 3 degrees to about 6 degrees,the transition to fusion is gradual and is expected to take 1-3 years.For motion of less than 3 degrees, the fusion transition happens morequickly and is expected to take less than two years or less than oneyear.

In another use, the dynamic intervertebral spacer provides a limitedrange of motion which continues to provide motion without completespinal fusion. A method of selecting a dynamic spacer for a non-fusionmay include steps of measuring the natural range of motion of thepatient at the level of the desired surgery and selecting a dynamicspacer with a range of motion limited to approximately the natural rangeof motion. The selected spacer may have a range of motion of withinabout 2 degrees of the natural range of motion.

Modification of the above-described assemblies and methods for carryingout the invention, combinations between different variations aspracticable, and variations of aspects of the invention that are obviousto those of skill in the art are intended to be within the scope of theinvention disclosure.

What is claimed is:
 1. A dynamic intervertebral spacer comprising: amonolithic ring having an anterior portion, a posterior portion, a firstlateral portion, a second lateral portion opposite the first lateralportion, and an open center portion; wherein the ring is split in theanterior portion and superior and inferior surfaces on a first sidethereof are vertically offset from superior and inferior surfaces on asecond side thereof; wherein the posterior portion of the ring isconfigured to act as a torsion spring to allow the vertical offset ofthe first and second lateral portions to decrease under load on thering; and wherein the first and second sides of the ring each have atleast one bone screw, wherein the bone screw(s) on one side areconfigured to attach to a superior vertebral body and the bone screw(s)on the another side are configured to attach to an inferior vertebralbody.
 2. The spacer as in claim 1, wherein the ring has first and secondopposed faces at the split which move with respect to one another underload on the ring from adjacent vertebral bodies.
 3. The spacer as inclaim 2, wherein the opposed faces are planar.
 4. The spacer as in claim2, wherein the vertical offset resists the compression with a springforce in the range from 20 N/mm to 40000 N/mm.
 5. The spacer as in claim1, wherein the monolithic ring is configured to elastically resistflexion as a patient's spine goes through flexion and extension.
 6. Thespacer as in claim 5, wherein the monolithic body comprises a polymer.7. The spacer as in claim 6, wherein the polymer is selected from thegroup consisting of polyether ether ketones (PEEK), polyaryl etherketones (PAEK), and their composites, such as carbon fiber reinforced orwith radiopaque compounds.
 8. The spacer as in claim 5, wherein themonolithic body comprises a metal.
 9. The spacer as in claim 8, whereinthe metal is selected from the group consisting of titanium, and itsalloys such as nitinol, cobalt chrome molybdenum and variants.
 10. Thespacer as in claim 1, wherein the vertical offset is in the range from0.05 mm to 3.0 mm.
 11. The spacer as in claim 1, wherein the superiorsurface has a convex geometry.
 12. The spacer as in claim 1, wherein thering includes an open center space extending from the superior to theinferior surface configured to receive a bone graft material.
 13. Thespacer as in claim 1, wherein a first portion of the anterior portionconnected to the first lateral portion has the bone screw and a secondportion of the anterior portion connected to the second lateral portionhas another bone screw.
 14. The spacer as in claim 1, wherein at least apart of the posterior portion has an attachment feature on at least oneof the superior and anterior surfaces thereof.